1. Field of the Invention
This invention relates to a method for treating erectile dysfunctionality by injecting pharmacological agents into the corpora cavemosa of the penis. The present invention employs an improved method for injecting pharmacological agents into the corpora cavernosa of the penis which does not require a hypodermic needle and the attendant problems associated with the use of hypodermic needles to inject pharmacological agents into the penis and to provide a new treatment option to many patients with erectile dysfunctionality.
2. Description of the Prior Art
There are a variety of methods for the treatment of erectile disfunctionality. These methods include vacuum/constriction devices, cutaneous placement of pharmacological ointment, pharmacological injection using a hypodermic needle, penile prostheses, vascular surgery, and urethral implantation of pharmacological agents. (See Kim et at, "Advances In the Treatment of Organic Erectile Dysfunction", Hospital Practice, Apr. 15, 1997). The present invention is directed towards an improved method of delivering pharmacological agents to the penis for the treatment of erectile dysfunctionality.
The direct injection of pharmacological agents by a needle into the penis has many drawbacks. First, many patients have an aversion to Injecting their penis with a hypodermic needle. Other side effects of intracavernous injection include pain, hematoma, priapism, and fibrotic complications, including penile nodules, curvature and fibrotic plaques (See Helistrom, "A Double-Blind Placebo-Controlled Evaluation Response of the Erectile Response To Transurethral Alprostadil" Urology, (1996). Additionally, needle injection involves a risk of accidentally puncturing a nerve or blood vessel (See "Biojector.RTM. 2000 Product Information and Benefits of the Biojector.RTM. 2000 Needle-Free Injection Management System", by Biolet, Inc.). Long term patent compliance with needle injection of the penis is less than 50% (see Hellstrom, supra).
Another prior art method of delivering pharmacological agents to the penis is intraurethral insertion of a suppository. The primary pharmacological agent delivered by this method is alprostadil. The drawbacks of this method include the cost, estimated to be $20-25 per application, pain, and the efficacy. Studies have shown that the transurethral suppository method of treatment has an efficacy of less than 50%, even where the dosage of alprostadil is 1000 micrograms (See Kim, supra).
Mechanical methods of inducing a penile erection include vacuum/constriction devices. Such devices are clumsy and cumbersome. The cumbersome nature of these devices interferes with user spontaneity. Another drawback of this treatment method is a lack of erectile rigidity proximal to the constriction band of such devices. This results in the swinging of the penis about the constriction band, in a manner similar to the movement of a pendulum. Such movement is referred to as a "hinge" effect.
Two methods of treating erectile dysfunctionality which require surgery are the implantation of a penile prosthesis and vascular surgery. Surgery is expensive and may not be suitable for all patients. Additionally, the implantation of a penile prosthesis precludes subsequent use of vasoactive injection therapy and vacuum/constriction devices. Vascular surgery is presently considered investigational and should only be performed in a research setting (Kim, supra).
A third treatment comprising cutaneous placement of a pharmacological ointment, has low response rates (Kim, supra).
The present invention provides an improved method of treating erectile dysfunctonality. In particular, the present invention provides an improved method for delivering pharmacological agents to the corpora cavemosa of the penis. The advantages of the present invention over prior art methods for delivering pharmacological-agents to the corpora cavernosa of the penis include less pain, greater speed, less blood loss, less invasion, less tissue damage and less risk of transmitting blood borne diseases and viruses than methods involving the use of a hypodermic needle. The present invention does not require the use of a hypodermic needle in order to deliver pharmacological agents to the corpora cavernosa of the penis. Infection can result from the use of a needle that is improperly sterilized. Accordingly, the invention does not involve the needle disposal or Infection problems of methods which use hypodermic needles. Additionally, there is no risk of a stick injury from the use of a used needle.
The present invention provides several psychological advantages over intravenous injection methods. These advantages include no needle anxiety, no painful injections and improved sexual spontaneity.
The present invention provides several physical advantages over intracavernous injection. These advantages include less penile trauma, less hematoma, less penile induration, less plaque, less penile fibrosis, less penile deformation, less penile shortening, and less blood vessel injury.
The present invention does not require surgery. It is therefore far less expensive than methods of treating erectile dysfunctionality which require surgery.
The only device required to use the present invention is a hand held injection unit for injecting pharmacological agents into the side of the penis, without the use of a hypodermic needle. This hand held device is smaller and less cumbersome than vacuum/constriction devices.